Biological Allograft Chain Tissue Implant

NCT04064710 | Unknown FDA Device

• 1 other identifier: SP-18-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.

Conditions

Vertebral Body Compression Fracture(s)

Outcome Measures

Primary Outcomes (1)

• Evaluate fracture stability assessed via subject- reported pain over time

  Subject-reported pain over time using the allograft tissue will be assessed using the Visual Analog Scale (VAS) for back pain on a scale of 0mm (no pain) to 100mm (worst pain imaginable).

  12 months

Secondary Outcomes (4)

• Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire

  12 months

• Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)

  12 months

• Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale

  12 months

• Frequency of Implant Related Complications

  12 months

Study Arms (1)

Allograft Tissue

OTHER

Allograft tissue product for patients with painful vertebral compression fractures

Procedure: Vertebral Body Augmentation; Device: Manual Surgical Instruments

Interventions

Vertebral Body Augmentation PROCEDURE

Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.

Allograft Tissue

Manual Surgical Instruments DEVICE

Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.

Allograft Tissue

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Skeletally mature adult ≥ 50 years of age at the time of surgery;
• Currently in an independent living environment;
• One- or two- level, acute (within six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
• Adequate vertebral body height and geometry for insertion of the access instruments, as determined by the investigator and suitable candidate for standard kyphoplasty or vertebroplasty procedure;
• VAS back pain score ≥ 70 mm on a 100 mm scale;
• Has central pain over the spinous process upon palpation at the planned vertebral index level;
• Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.

You may not qualify if:

• More than two levels with a vertebral compression fracture;
• Previous treated or untreated vertebral compression fracture at the to be treated level(s);
• Uncorrectable coagulopathy;
• Previous instrumented spinal surgery;
• Significant vertebral collapse defined as \> 70% of original vertebral height, or a burst, or pedicle fracture;
• Degenerative scoliosis, defined as Cobb angle \> 20° at any level;
• Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
• Disabling back pain secondary to causes other than acute fracture;
• Inability to walk or stand prior to sustaining the vertebral compression fracture;
• Active systemic or local infection;
• Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
• Morbid obesity defined as a body mass index \> 40 kg/m2;
• Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
• Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
• Currently involved in study of another investigational product that may affect outcome;

Sponsors & Collaborators

• Lenoss Medical: lead
• MCRA: collaborator

Study Sites (5)

University of Colorado Denver | Anschutz Medical Campus

Denver, Colorado, 80204, United States

RECRUITING

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Clinical Investigations LLC

Edmond, Oklahoma, 73013, United States

ACTIVE NOT RECRUITING

Central Study Contacts

Dom Messerli

CONTACT

484-988-0477; dom.messerli@lenoss.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: June 10, 2019
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)